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    Summary
    EudraCT Number:2008-001635-34
    Sponsor's Protocol Code Number:3129K7-2001-WW
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-001635-34
    A.3Full title of the trial
    A Phase 2 Study of Inotuzumab Ozogamicin (CMC-544) in Subjects With Indolent
    Non-Hodgkin’s Lymphoma (NHL) That is Refractory to or has Relapsed After Rituximab and Chemotherapy or Radioimmunotherapy
    A.4.1Sponsor's protocol code number3129K7-2001-WW
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research & Development
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInotuzumab Ozogamicin
    D.3.2Product code CMC-544
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInotuzumab Ozogamicin
    D.3.9.2Current sponsor codeCMC-544
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typecalicheamicin-conjugated humanized anti-CD22 monoclonal IgG4 antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Indolent Non-Hodgkin's Lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the antitumor activity of inotuzumab ozogamicin in subjects with indolent NHL who have relapsed or are refractory to rituximab and chemotherapy, or anti CD-20 radioimmunotherapy (RIT), as measured by the Overall Response Rate (ORR).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of inotuzumab ozogamicin in the treatment of subjects with indolent NHL
    To evaluate CR, PFS, DR and OS in subjects with indolent NHL
    To determine the ORR, CR, PFS, DR and OS in subjects with follicular NHL
    To acquire data required for evaluation of the population pharmacokinetic (PK) profile of inotuzumab ozogamicin.
    To evaluate the concentration-effect relationship of cardiac QT measures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have been previously diagnosed with CD22-positive, indolent NHL
    (defined as follicular, marginal zone, or SLL) that has progressed after ≥2 prior therapies.
    2. Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 RIT. Subjects must have exhibited no response or have progressed within 6 months from the completion of rituximab or rituximab containing therapy or within 12 months of the completion of RIT.
    3. Measurable disease with at least one lymph node or tumor mass >1.0 cm in the greatest transverse diameter (GTD) and the product of the diameters (PD) ≥2.25cm2 as measured by CT or MRI.
    4. Age 18 years or older.
    5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (corresponds to Karnofsky Performance Status (KPS) ≥60%).
    6. Life expectancy ≥12 weeks.
    7. Adequate bone marrow function, defined as absolute neutrophil count (ANC) ≥1.5 x 109/L (≥1,500/μL), hemoglobin >9.0 g/L, and platelet count ≥100 x 109/L (≥100,000/μL) with no packed red blood cell (PRBC) or platelet transfusions 2 weeks before the first dose of test article.
    8. Serum creatinine ≤2.0 x upper limit of normal (ULN) and urine protein/creatinine ratio ≤0.5.
    9. Adequate hepatic function, defined as total bilirubin ≤1.5 x ULN and aspartate
    aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 x ULN.
    10. Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
    11. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 to 42 days after the last dose of test article. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
    12. Signed and dated institutional review board (IRB)/independent ethics committee
    (IEC)-approved informed consent form before any screening procedures are performed.
    E.4Principal exclusion criteria
    1. Candidate for potentially curative therapies in the opinion of the investigator.
    2. History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction
    syndrome (SOS).
    3. Prior allogeneic hematopoietic stem cell transplant (HSCT).
    4. Autologous HSCT within the last 6 months before receiving test article.
    5. Prior treatment with inotuzumab ozogamicin.
    6. Subjects with intolerance to or who have had a severe allergic or anaphylactic reaction to any humanized monoclonal antibodies.
    7. Major surgery, not related to debulking surgical procedures, within 28 days before the first dose of test article.
    8. Have received any chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices within 28 days before administration of the first dose of test article. Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 14 days before the first dose of inotuzumab ozogamicin
    9. Pregnant or breastfeeding women.
    10. Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
    11. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
    12. Current or chronic hepatitis B or hepatitis C infection, or known seropositivity for human immunodeficiency virus (HIV). HIV testing may need to be performed in accordance with local regulations or local practice.
    13. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function,
    unstable pulmonary condition).
    14. Any evidence of serious active infection (eg, requiring an IV antibiotic or antiviral agent within 4 weeks of test article administration; an active infection requiring oral anti-infective agents within 2 weeks of test article administration; or any other history of deep tissue infection suggestive of underlying immune system dysfunction [fascitis, deep tissue abscess, osteomyelitis, articular septic arthritis] within 12 months of test article administration).
    15. Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for 2 years or more.
    16. Primary effusion lymphoma.
    17. Left ventricular ejection fraction (LVEF) that is greater than Grade 1 (NCI CTCAE v3), or the presence of NYHA stage III or IV congestive heart failure.
    18. Previous myocardial infarction or pulmonary hypertension within the past 6 months.
    19. Known system vasculitides (eg, Wegener granulomatosis, polyarteritis nodosa, systemic lupus erythematosus), primary or secondary immunodeficiency (eg, severe inflammatory disease).
    20. History of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
    21. Administration of a live vaccine within 6 weeks of the first dose of test article.
    22. Any major illness/condition or abnormal laboratory finding that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the confirmed overall response rate (ORR) at the time of the final analyses, which will be conducted approximately 12 months after the last indolent NHL patient received his/her last dose, or after all indolent NHL patients have completed disease follow-up, whichever occurs first.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cardiac QT measures
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last follow-up visit of the last subject enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will receive treatment in accordance with local standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-27
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